Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-06-30

Brief Summary

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Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).

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Detailed Description

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Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM). Maximum lesion size was compared between the two imaging types. Subject data from both scans was planned to be included in a multi-reader evaluation; however, due to premature stop of the study, multi-reader data was not collected.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CE-BMRI

Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.

Group Type EXPERIMENTAL

CE-BMRI

Intervention Type DEVICE

Contrast-enhanced breast imaging using Magnetic Resonance

DE-CEDM

Intervention Type DEVICE

Breast imaging using Dual-energy, contrast-enhanced digital mammography

Interventions

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CE-BMRI

Contrast-enhanced breast imaging using Magnetic Resonance

Intervention Type DEVICE

DE-CEDM

Breast imaging using Dual-energy, contrast-enhanced digital mammography

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Woman 21 years of age or older
* The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained.
* Newly diagnosed with Breast Cancer (DCIS or invasive) identified through core biopsy or fine-needle aspiration (FNA) within last 30 days.
* Will have or have had a bilateral CE-BMRI performed within 30 days AFTER the new breast cancer diagnosis.

Exclusion Criteria

* Woman who has already had a lumpectomy for the index lesion.
* Woman undergoing neoadjuvant chemotherapy treatment, hormone treatment or radiation therapy.
* Woman who is pregnant or who believe she may be pregnant.
* Woman who has breast implant.
* Woman who has a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (e.g., allergy to either agent or severely impaired renal function).

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No